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U.S. Department of Health and Human Services

Inventory of Effective Food Contact Substance (FCS) Notifications

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FCN No. 572

Addivant

According to Section 409(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act, food contact substance notifications (FCNs) are effective only for the listed manufacturer and its customers. Other manufacturers must submit their own FCN for the same food contact substance and intended use.

Food Contact Substance: Amines, bis(hydrogenated rape oil alkyl) methyl, N-oxides (CAS Reg. No. 204933-93-7).
Notifier: Addivant
Manufacturer: Addivant
Intended Use: As an antioxidant in the manufacture of polyethylene and polypropylene homopolymer and copolymers complying with 21 CFR 177.1520(c).
Limitations/Specifications*: 1. For use only at levels not to exceed 0.1 weight percent high density polyethylene polymers and copolymers complying with 21 CFR 177.1520(c), items 2.1, 2.2, 2.3, 3.1a, 3.1b, 3.2a, 3.6 (with density not less than 0.94 grams per cubic meter) and 5. The finished polymers may be safely used in applications involving contact with all food types under Conditions of Use B through H, as described in Tables 1 and 2. 2. For use only at levels not to exceed 0.1 weight percent polypropylene polymers and copolymers complying with 21 CFR 177.1520. The finished polymers may be safely used in applications involving contact with all food types under Conditions of Use B through H, as described in Tables 1 and 2.
Effective Date: Mar 28, 2006
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
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